FIRST QUARTER 2016


“Data can be combined in ways that we’ve dreamed about but have been unable to do,” he said in a November video message to a meeting of the nonprofit Clinical Data Interchange Standards Consortium, or CDISC. But he also noted that it is still a struggle to make sense of all the data available.


“The regulators and the regulated agreed a better and more efficient job could be done if the data could be submitted in a more standardized fashion,” he said.


Califf built on those remarks the same week at a meeting held by the Friends of Cancer Research advocacy group in Washington, describing the gap between FDA and the National Institutes of Health in how each agency defined biomarkers, data points which can help speed clinical trials by acting as a surrogate for longer-term outcomes.


“Between the FDA and NIH, and within each organization, we had entirely different meanings for exactly the same terms,” he said. “You’d think we’d be well beyond that. But on the FDA side we’re seeing entire companies started based on a total incorrect assumption about a biomarker being used as a surrogate, and what it takes to get there.”


Rebecca Kush, the president of CDISC, predicted that Califf will push the FDA to promote higher-quality data.


“We need good, clean data, we need evidence that we can trust, and we need it in standard formats, so we can tell if that biomarker works,” she said.


At the same time, Califf thinks that clinical trial data need to better reflect the real world. In 2012, legislation that renewed the FDA’s authority to collect user fees from regulated industry also instructed the agency to incorporate views from the people ultimately using treatments. To that end, Califf has promoted the agency’s creation of patient engagement advisory committees. He also thinks that the FDA should promote diversity in clinical trials by including more elderly, women, and racial or ethnic minorities.


“One challenge that remains for FDA is ensuring that research participants are representative of the patients who will use the medical product,” Califf wrote in January on the FDA’s website.


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At the end of February, the agency will hold a public meeting


about how it can promote more participation from underrepresented demographics.


He’s also been a big proponent of ClinicalTrials.gov, a public database with data from more than 200,000 studies, and will likely use his platform at the FDA to promote transparency of clinical trial data.


Confirmation Impact With his confirmation, Califf also will be in a better position to tackle high-profile issues, including one that held up his nomination. Earlier this month, Califf took the lead in announcing new FDA policies about opioid painkiller approvals, part of a broader administration effort to address the prescription drug abuse crisis.


“Having a confirmed commissioner actually helps address these issues that require coordination with other agencies,” McClellan said.


Even some of the critics who expressed concern about Califf have acknowledged that he is qualified to lead the agency and focus on these issues.


Sen. Elizabeth Warren one of those critics, questioned Califf ’s ties to the pharmaceutical industry at his confirmation hearing. But in January, before voting to move his nomination out of the Senate Health,


Education, Labor and Pensions Committee, that Califf had assuaged the


Massachusetts Democrat submitted a statement for the record explaining concerns.


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“There are substantial advantages to having a leader of the FDA who is a serious, front-line researcher who understands the importance of advancing cutting-edge work that will advance the health of millions of Americans — and who is sensitive to the conflicts of interest that can arise in industry-funded research,” she said in the statement.


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